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Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR)

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ClinicalTrials.gov Identifier: NCT02796261
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Orbus Therapeutics, Inc.

Study Description
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Brief Summary:
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Condition or disease Intervention/treatment Phase
Anaplastic Astrocytoma Recurrent Anaplastic Astrocytoma Drug: Eflornithine Drug: Lomustine Phase 3

Detailed Description:

This study will consist of 4 study periods of up to 50 months in total, consisting of:

Screening Period - A maximum screening duration of 4 weeks.

Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.

End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.

Follow-Up Period - Up to 24 months.

A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Study Start Date : July 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Eflornithine + Lomustine
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
 Drug: Eflornithine
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Other Name: DFMO

Drug: Lomustine
Lomustine 90 mg/m2 administered orally once every 6 weeks
Other Names:
  • CCNU
  • CeeNU
  • Gleostine
Active Comparator: Lomustine
Lomustine dosed every 6 weeks
 Drug: Lomustine
Lomustine 110 mg/m2 administered orally once every 6 weeks
Other Names:
  • CCNU
  • CeeNU
  • Gleostine


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 4 years ]
  2. Objective response rate (ORR) [ Time Frame: 4 years ]

Other Outcome Measures:
  1. Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria [ Time Frame: 4 years ]
  2. OS rate at 18 months (OS-18) [ Time Frame: 18 months ]
  3. Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples [ Time Frame: 4 years ]
  4. Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]
  5. PK - Area under the curve (AUC) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Surgical or biopsy-proven diagnosis of WHO grade 3 AA.

  • First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:

    1. Gd-contrast lesion margins are not clearly defined,
    2. Gd-contrast lesions are only measurable in one dimension,
    3. Gd-contrast lesion has two perpendicular diameters less than 10 mm,
    4. Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
    5. Recent histopathological confirmation of WHO grade 3 AA
  • Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
  • Completion of EBRT ≥ 6 months prior to randomization.
  • A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.
  • Karnofsky Performance Status (KPS) score of ≥ 70.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not eligible for study participation:

  • MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
  • Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
  • Prior systemic therapy for recurrence of AA.
  • Presence of extracranial or leptomeningeal disease.
  • Prior lomustine use.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
  • Pregnant or breastfeeding.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796261


Contacts
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Contact: Marietta Franco, MS 6504506634 marietta.franco@orbustherapeutics.com
Contact: Kathleen Villamejor, BS 6506569424 kathleen.villamejor@orbustherapeutics.com

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Sponsors and Collaborators
Orbus Therapeutics, Inc.
Investigators
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Study Director: Marietta Franco, MS Orbus Therapeutics, Inc.
More Information
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Responsible Party: Orbus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02796261     History of Changes
Other Study ID Numbers: OT-15-001
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Orbus Therapeutics, Inc.:
Anaplastic Astrocytoma
Grade 3 Glioma
Glioma
Eflornithine
Brain Cancer
Brain Tumor
Neuro-oncology
 Progressive Anaplastic Astrocytoma
Recurrent Anaplastic Astrocytoma
Progressive Glioma
Recurrent Glioma
Malignant Glioma
Progressive Brain Tumor
Recurrent Brain Tumor
Additional relevant MeSH terms:
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Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Eflornithine
Lomustine
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors